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A Prospective, Single-center, Randomized Controlled Clinical Study Evaluating the Efficacy and Safety of Hyperbaric Oxygen Therapy as an Adjunctive Treatment for Chronic Heart Failure

NCT07311109 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-12-30

No results posted yet for this study

Summary

This study aims to investigate whether adjunctive hyperbaric oxygen therapy, compared to guideline-directed medical therapy with the "New Four Pillars" (ARNI/ACEI/ARB + β-blocker + MRA + SGLT2 inhibitor) alone, improves cardiac function in patients with chronic heart failure, and to evaluate its efficacy and safety.

Conditions

  • Chronic Heart Failure With Reduced Ejection Fraction

Interventions

OTHER

hyperbaric oxygen therapy

The therapy is administered in a multi-place chamber at a pressure of 0.2 MPa (2 ATA). The treatment protocol per session is as follows: 20 minutes of compression, followed by two 30-minute periods of oxygen inhalation via mask, separated by a 10-minute air break, and finally 20 minutes of decompression. The total duration per session is 110 minutes.

Sponsors & Collaborators

  • Fujian Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-15
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07311109 on ClinicalTrials.gov